Device for performing a surgical procedure and method

ABSTRACT

A device including a first member extending along an axis between a first end and a second end. The first end includes a first portion spaced apart from a second portion by a gap extending parallel to the axis. An inner surface of the first portion and an inner surface of the second portion defining a cavity. A pivoting member is movably disposed in the cavity and includes an inner surface defining a passageway. A second member is disposed within the passageway. The pivoting member is movable between a first orientation such that the gap has a first width and the pivoting member is rotatable to a selected trajectory relative to the axis and a second orientation such that the gap has a second width that is less than the first width and the second member is fixed in the selected trajectory. Methods of use are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal structures, and more particularly to asurgical system and method that include a device configured to hold asurgical instrument while a surgical procedure is performed.

BACKGROUND

Height loss is commonly associated with fractures, such as, for example,spinal fractures, typically referred to as vertebral compressionfractures. A large segment of osteoporotic patients experience vertebralcompression fractures, with an estimated 700,000 such fracturesoccurring annually. Kyphoplasty is a minimally invasive procedure thatis used to treat vertebral compression fractures using a combination ofvertebroplasty utilizing a bone void filler, such as, for example, bonecement with balloon catheter technology. The kyphoplasty procedurerestores height of the collapsed spinal bone which diminishes associatedback pain.

Kyphoplasty procedures may also be used to treat fractures in otherareas of a patient's body, such as, for example, a distal radius of thepatient. To treat a distal radius fracture using a kyphoplastyprocedure, an inflatable bone tamp (IBT) is utilized. The IBT is used topercutaneously reduce comminuted, articular depressions in a controlledmanner. Fracture morphologies, such as, for example, “die-punch”fractures are especially suited for correction by an IBT. IBTs aredeployed to a surgical site, such as, for example, a bone defect througha working cannula. IBTs create well-defined voids. After the void iscreated by the IBT, the IBT is removed from the cannula and a material,such as, for example a bone void filler is delivered through the cannulaand into the void. The bone void filler may be used in conjunction withpercutaneous pins, ex-fixes, screws and/or plates for fracture fixation.

In conventional kyphoplasty a procedure, the IBT is inserted adjacentthe bone defect by inserting the IBT through a cannula. An inflatablemember of the IBT is expanded to create a void in or adjacent the bonedefect. After the IBT creates the void, the IBT is removed from thecannula and a bone void filler is delivered through the cannula to thevoid in order to at least partially fill the void. It is thereforeimportant that the cannula be properly oriented with respect to the bonedefect. In conventional kyphoplasty procedures, the cannula is held at adesired trajectory by a physician or physician's assistant, so that theIBT or bone void filler may be delivered through the cannula to alocation adjacent the bone defect or void created by the IBT.

Percutaneous delivery of IBT or bone filler material through the cannulato a bone defect or bone void can be difficult. For example, the IBT orbone void filler material may get stuck in the cannula. Furthermore, thedistal end of the cannula must be positioned adjacent to the bone defector bone void to allow the IBT or bone void filler to be deliveredthrough the cannula to the bone defect or bone void. There is oftenlittle soft tissue and/or bony anatomy to hold the cannula in a stableposition during delivery of the IBT or bone filler material. Tostabilize the cannula, a surgical assistant is often required to providean extra pair of hands to hold the cannula while a surgeon delivers theIBT or the bone filler material to the bone defect or bone void throughthe cannula. The present disclosure provides a device that acts as asecond pair of hands to hold the cannula at a fixed trajectory to ensurethat the cannula is properly positioned relative to the bone defect orbone void. This disclosure describes an improvement over these prior arttechnologies.

SUMMARY

Accordingly, a surgical system and method for correction of a boneinjury or disorder are provided. In one embodiment, in accordance withthe principles of the present disclosure, the surgical system includes adevice for performing a surgical procedure. The device includes a firstmember extending along a longitudinal axis between a first end and asecond end. The first end includes a first portion spaced apart from asecond portion by a gap extending parallel to the longitudinal axis. Aninner surface of the first portion and an inner surface of the secondportion defining a cavity. A pivoting member is movably disposed in thecavity and includes an inner surface defining a passageway. A secondmember is disposed within the passageway. The pivoting member is movablebetween a first orientation such that the gap has a first width and thepivoting member is rotatable to a selected trajectory relative to thelongitudinal axis and a second orientation such that the gap has asecond width that is less than the first width and the second member isfixed in the selected trajectory.

In one embodiment, in accordance with the principles of the presentdisclosure, the surgical system includes a device comprising a firstmember extending along a longitudinal axis between a first end and asecond end. The first end includes a first portion spaced apart from asecond portion by a gap extending parallel to the longitudinal axis. Aninner surface of the first portion and an inner surface of the secondportion define a substantially spherical cavity. The first portionincludes a post extending parallel to the longitudinal axis and thesecond portion includes a hook configured to engage the post to fix thefirst portion relative to the second portion. A substantially sphericalpivoting member is movably disposed in the cavity and includes an innersurface defining a passageway. The cavity and the pivoting member definea ball and socket joint. A second member is disposed within thepassageway and includes an inner surface defining a second passagewayhaving an inflatable bone tamp, a bone void filler, bone void fillertool or working cannula disposed therein. The pivoting member is movablebetween a first orientation such that the gap has a first width and thepivoting member is rotatable to a selected trajectory relative to thelongitudinal axis and a second orientation such that the gap has asecond width that is less than the first width and the second member isfixed in the selected trajectory. The hook is spaced apart from the postwhen the pivoting member is in the first orientation and the hookengages the post when the pivoting member is in the second orientation.

In one embodiment, in accordance with the principles of the presentdisclosure, a method for repairing a bone is provided. The methodcomprises the steps of: providing a device comprising: a first memberextending along a longitudinal axis between a first end and a secondend, the first end including a first portion spaced apart from a secondportion by a gap having a first width and extending parallel to thelongitudinal axis, the first portion including a post extending parallelthe longitudinal axis and the second portion including a hook configuredto engage the post to fix the first portion relative to the secondportion, an inner surface of the first portion and an inner surface ofthe second portion defining a cavity, a pivoting member movably disposedin the cavity including an inner surface defining a passageway, and asecond member disposed within the passageway; creating an access path toa defect in a bone; inserting the second end of the first member throughthe access path; inserting a second member into the passageway; rotatingthe pivoting member to a selected trajectory relative to thelongitudinal axis such that a distal end of the second member ispositioned adjacent the bone defect; and engaging the hook with the postsuch that the gap has a second width that is less than the first widthand the second member is fixed in the selected trajectory.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a frontal view of one embodiment of components of a system inaccordance with the principles of the present disclosure;

FIG. 2 is a frontal view of one embodiment of the system shown in FIG. 1in accordance with the principles of the present disclosure;

FIG. 3 is a frontal view of one embodiment of the system shown in FIG. 1in accordance with the principles of the present disclosure;

FIG. 4 is a side, cross sectional view of components of the system shownin FIG. 1;

FIG. 5 is a side, cross sectional view of components of the system shownin FIG. 1;

FIG. 6 is a side, cross sectional view of components of a system inaccordance with the principles of the present disclosure;

FIG. 7 is a side, cross sectional view of components of a system inaccordance with the principles of the present disclosure;

FIG. 8 is a side, cross sectional view of the system shown in FIG. 7.

Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system and method for bone repair. It is envisioned thatthe surgical system and method may be employed in applications such asfor correction of fractures, depressions and breaks. For example, thesurgical system and method include a device configured to hold asurgical instrument while performing a surgical procedure to treat abone defect, such as, for example a fracture.

In one embodiment, the system and method include a device configured tohold a cannula having a ball and socket configuration. The ball isconfigured to interface with a socket in a tail of the device. The tailhas a latch at a distal end configured to tighten the socket around theball. The tail also has a hinge with strain relief to tighten around theball.

It is contemplated that one or all of the components of the surgicalsystem may be disposable, peel-pack, pre-packed sterile devices. One orall of the components of the surgical system may be reusable. Thesurgical system may be configured as a kit with multiple sized andconfigured components, such as, for example, balloons that are preformedto have different sizes and shapes.

It is envisioned that the present disclosure may be employed to treatbones, such as, for example, spinal bones or arm bones. It should beunderstood that the present principles are applicable to any bonestructures, including but not limited to bones of the spine, legs, feet,hands, etc. It is contemplated that the present disclosure may beemployed with other osteal and bone related applications, includingthose associated with diagnostics and therapeutics. It is furthercontemplated that the disclosed surgical system and methods mayalternatively be employed in a surgical treatment with a patient in aprone or supine position, and/or employ various surgical approaches,including anterior, posterior, posterior mid-line, direct lateral,postero-lateral, antero-lateral, etc. approaches in the arm, spine orother body regions. The present disclosure may also be alternativelyemployed with procedures for treating the muscles, ligaments, tendons orany other body part. The system and methods of the present disclosuremay also be used on animals, bone models and other non-livingsubstrates, such as, for example, in training, testing anddemonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following disclosure includes a description of a surgical system forholding a surgical instrument while a surgical procedure is performed.The disclosure also includes a description of related methods ofemploying the disclosed surgical system. Alternate embodiments are alsodisclosed. Reference will now be made in detail to the exemplaryembodiments of the present disclosure, which are illustrated in theaccompanying figures. Turning now to FIGS. 1-5, there are illustratedcomponents of a surgical system, such as, for example, a surgical system30 and embodiments in accordance with the principles of the presentdisclosure.

The components of system 30 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites, depending on the particular application and/or preference ofa medical practitioner. For example, the components of system 30,individually or collectively, can be fabricated from materials such asstainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations. Various components of system 30 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of system 30, individually or collectively,may also be fabricated from a heterogeneous material such as acombination of two or more of the above-described materials. Thecomponents of system 30 may be monolithically formed, integrallyconnected or include fastening elements and/or instruments, as describedherein.

System 30 is employed, for example, with an open, mini-open or minimallyinvasive surgical technique to treat a bone defect, such as, for examplea fracture. System 30 includes a tail, such as, for example, a firstmember 32 extending along a longitudinal axis A between a first end 34and a second end 36. End 34 includes a first portion 38 spaced apartfrom a second portion 40 by a gap 42 extending parallel to axis A. It isenvisioned that gap 42 may be disposed at alternate orientationsrelative to axis A, such as, for example, perpendicular and/or otherangular orientations such as acute or obtuse and/or may be offset orstaggered and/or may be disposed at alternative angular orientationsrelative to axis A, depending on the requirements of a particularapplication. In one embodiment, portions 38, 40 are resiliently biasedaway from one another.

An inner surface 44 of portion 38 defines a first hemispherical chamber46 and an inner surface of portion 40 defines a second hemisphericalchamber 50. Chambers 46, 50 define a substantially spherical cavity 52extending transverse to axis A. It is envisioned that all or only aportion of chamber 46, chamber 50 and/or cavity 52 may be variouslyconfigured and dimensioned, such as, for example, planar, concave,convex, hemispherical, spherical, polygonal, irregular, uniform,non-uniform, staggered, tapered, consistent or variable, depending onthe requirements of a particular application. It is further envisionedthat cavity 52 may be disposed at alternate orientations relative toaxis A, such as, for example, perpendicular and/or other angularorientations such as acute or obtuse and/or may be offset or staggeredand/or may be disposed at alternative angular orientations relative toaxis A, depending on the requirements of a particular application.

In one embodiment, shown in FIGS. 1 and 2, portion 38 includes a post 54extending parallel axis A and portion 40 includes a hook 56 configuredto engage post 54 to fix portion 38 relative to portion 40. Hook 56 isdisposed on a column 58 extending parallel to axis A and is rotatablerelative to column 58 in a direction shown by arrow B or a directionshown by arrow BB to engage post 54. This configuration may be reversed.That is, portion 40 can include post 54 and portion 38 can include hook56 and column 58. It is envisioned that post 54 and/or column 58 may bedisposed at alternate orientations relative to axis A, such as, forexample, perpendicular and/or other angular orientations such as acuteor obtuse and/or may be offset or staggered and/or may be disposed atalternative angular orientations relative to axis A, depending on therequirements of a particular application. It is further envisioned thatportion 38 may be fixed relative to portion 40 in alternate fixationconfigurations, such as, for example, friction fit, pressure fit,locking protrusion/recess, locking keyway, threaded engagement, latchand/or adhesive.

In one embodiment, shown in FIGS. 3 and 4, portion 38 includes an eyelet60 having an inner surface defining a hole 62 extending transverse toaxis A. Hook 56 is configured for disposal in hole 62 to fix portion 38relative to portion 40. This configuration may be reversed. That is,portion 40 may include eyelet 60 and portion 38 may include hook 56. Itis envisioned that hole 62 may be disposed at alternate orientationsrelative to axis A, such as, for example, perpendicular and/or otherangular orientations such as acute or obtuse and/or may be offset orstaggered and/or may be disposed at alternative angular orientationsrelative to axis A, depending on the requirements of a particularapplication.

End 36 includes an aperture 64 extending through a first surface 66 anda second surface 68 of end 36. Aperture 64 is configured to receive anengagement device, such as, for example a pin or K-wire 70 configured tofix member 32 relative to the anatomy of a patient. It is envisionedthat end 36 may include one or a plurality of apertures 64. It isfurther envisioned that system 30 may include one or a plurality ofpins/K-wires 70, corresponding to the number of apertures 64. In theembodiment shown in FIGS. 4 and 5, end 36 includes apertures 64extending perpendicular to axis A that alternate with apertures 64extending at an acute angle relative to axis A. However, it iscontemplated that the apertures 64 that extend at an acute anglerelative to axis A may be positioned proximally of the apertures 64 thatextend perpendicular to axis A. It is further contemplated that theapertures 64 that extend at an acute angle relative to axis A may bepositioned distally of the apertures 64 that extend perpendicular toaxis A. It is envisioned that apertures 64 may be disposed throughangular ranges in various orientations relative to axis A, such as, forexample, transverse or perpendicular and/or other angular orientationssuch as acute or obtuse, and/or may be offset or staggered. In someembodiments, apertures 64 and/or pins/K-wires 70 may be rough, textured,porous, semi-porous, dimpled and/or polished to facilitate engagementbetween apertures 64 and pins/K-wires 70.

A substantially spherical pivoting member 70 is movably disposed incavity 52 and includes an inner surface 74 defining a passageway 76.Cavity 52 and member 72 define a ball and socket joint. Passageway 76has a cylindrical cross sectional configuration and a uniform diameterthroughout the length of passageway 76. It is envisioned that all oronly a portion of member 70 may be variously configured and dimensioned,such as, for example, planar, concave, convex, hemispherical, spherical,polygonal, irregular, uniform, non-uniform, staggered, tapered,consistent or variable, depending on the requirements of a particularapplication. It is further envisioned that all or only a portion ofpassageway 76 may have alternate cross section configurations, such as,for example, oval, oblong, triangular, square, polygonal, irregular,uniform, non-uniform, offset, staggered, undulating, arcuate, variableand/or tapered, depending on the requirements of a particularapplication.

A second member, such as, for example a cannula 78 is disposed withinpassageway 76. In some embodiments, surface 74 includes a deformablematerial, such as, for example, silicone or elastomer (e.g.,synthetically produced butyl rubber or neoprene or a natural rubber)disposed about passageway 76 to facilitate engagement of cannula 78 withmember 72. Cannula 78 includes an inner surface 80 defining a secondpassageway 82 configured for disposal of an inflatable bone tamp or abone filler material in order to deliver the same to a surgical site,such as, for example a bone defect. Passageway 82 has a cylindricalcross sectional configuration and a uniform diameter throughout thelength of passageway 82. In some embodiments, member 70 comprises adeformable material, such as, for example, polypropylene such thatsurface 74 provides a friction fit with an outer surface of cannula 78.It is envisioned that all or only a portion of passageway 82 may havealternate cross section configurations, such as, for example, oval,oblong, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered,depending on the requirements of a particular application.

Member 72 is movable between a first orientation such that gap 42 has afirst width W1, as shown in FIG. 2, and member 72 is rotatable to aselected trajectory relative to axis A and a second orientation such gap42 has a second width W2, as shown in FIG. 1, that is less than firstwidth W1 and cannula 78 is fixed in the selected trajectory. That is, asmember 72 moves from the first orientation to the second orientation,surface 44 exerts a clamping force on member 72 to fix member 72relative to member 32.

In the embodiment including hook 56 and post 54, hook 56 is spaced apartfrom post 54 when member 72 is in the first orientation, as shown inFIG. 2, and hook 56 engages post 54 when member 72 is in the secondorientation, as shown in FIG. 1. In the embodiment including hook 56 andeyelet 60, hook 56 is spaced apart from eyelet when member 72 is in thefirst orientation, as shown in FIG. 3, and hook 56 is disposed withineyelet 60 when member 72 is in the second orientation, as shown in FIG.4.

When member 72 is in the first orientation, passageway 76 is rotatableto a selected angle through and within angular range α relative to axisa in a plurality of planes that lie in a cone configuration C, as shownin FIG. 5. The area and/or volume defined by cone C, which includes theconfiguration disposed between a transverse axis A1 and a circular baseB, is defined by the range of motion of passageway 76 axis A1. Theplurality of planes includes a locus of all straight line segments thatjoin axis A1 and base B. For example, passageway 76 is separatelyrotatable to a selected angle within angular range α in each planecorresponding to a particular straight line segment that lies in coneconfiguration C. It is contemplated that passageway 76 may rotatablethrough the individual diameters, chords, section and/or radii of base band/or other portions of cone C. In one embodiment, passageway 76 isrotatable to a selected angle within angular range α in a sagittal plane(SP), corresponding to a particular plane that lies in cone C. In oneembodiment, passageway 76 is rotatable to a selected angle withinangular range α in a transverse plane (TP), corresponding to aparticular plane that lies in cone C. In one embodiment, passageway 76is rotatable to a selected angle within angular range α in a coronalplane (CP), corresponding to a particular plane that lies in cone C.

In one embodiment, shown in FIGS. 7 and 8, member 72 includes a collet84 extending from a substantially spherical ball 86. Passageway 76extends through both collet 84 and ball 86. Collet 84 includes an outersurface having a uniform diameter along the length of collet 84. Atleast a portion of the outer surface of collet 84 is threaded. System 30includes a cap 88 having a first end including a threaded inner surface90 and a second end having with an angled inner surface 92 that is freeof threads. Threaded inner surface 90 is configured to engage thethreaded outer surface of collet 84 to engage cap 88 with collet 84. Asthreaded inner surface 90 engages the threaded outer surface of collet84, cap 88 is rotated in the direction shown by arrow D or arrow DD suchthat cap 88 translates relative to collet 84 in the direction shown byarrow E. As cap 88 translates in the direction shown by arrow E, angledinner surface 92 engages the outer surface of collet 84 causing innersurface 74 to engage cannula 78. Because surface 92 is angled, rotationof cap 88 in the direction shown by arrow D or arrow DD allows forincremental tightening of surface 74 about cannula 78 such that arestrictive force applied to cannula 78 can be adjusted by altering theamount of rotation of cap 88. When 90 is fully threaded with thethreaded outer surface of collet 84, cannula 78 becomes fixed relativeto member 72. That is, cap 88 is movable between a first orientationsuch that threaded inner surface 90 is spaced apart from the threadedouter surface of collet 84, as shown in FIG. 7 and cannula 78 is movablydisposed within passageway 76 and a second orientation such thatthreaded inner surface 90 engages the threaded outer surface of collet84 and cannula 78 is fixed within passageway 76.

In assembly, operation and use, system 30 is employed with a surgicalprocedure, such as, for a correction or treatment of a bone defect, suchas, for example, a fracture. It is contemplated that one or all of thecomponents of system 30 can be delivered or implanted as a pre-assembleddevice or can be assembled in situ. System 30 may be completely orpartially revised, removed or replaced. For example, system 30 can beemployed with a surgical correction treatment of an applicable conditionor injury of an affected portion of a patient, such as, for example, adistal radius or a vertebra. It is envisioned that system 30 may also beused to treat other affected portions of the patient, such as, forexample, a calcaneus bone, bones of the feet or hands, bones of thelegs, etc.

In use, to treat a fracture, a medical practitioner obtains access to asurgical site including the fractured bone in any appropriate manner,such as through incision and retraction of tissues. In one embodiment, adrill is employed to remove bone tissue to provide access to a repairsite. It is envisioned that system 30 can be used in any existingsurgical method or technique including open surgery, mini-open surgery,minimally invasive surgery and percutaneous surgical implantation,whereby the fractured or injured bone is accessed through amini-incision or sleeve that provides a protected passageway to thearea. Once access to the surgical site is obtained, the particularsurgical procedure can be performed for treating the injury or disorder.The configuration and dimension of system 30 is determined according tothe configuration, dimension and location of a selected section of thebone fracture and the requirements of a particular application.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for implantation of components ofsystem 30. This may include the use of a cannula or other device. Apreparation instrument (not shown) can be employed to prepare tissuesurfaces, as well as for aspiration and irrigation of a surgical regionaccording to the requirements of a particular surgical application.

Pins/K-wires 70 are positioned within through apertures 64 and aredisposed in the anatomy of the patient, such as, for example, tissue, tofix or stabilize member 32 relative to the anatomy of the patient, withcannula 78 positioned within passageway 76. Member 32 is stabilized withpins/K-wires 70.

In embodiments, that include cap 88, threaded inner surface 90 isaligned with the threaded outer surface of collet 84. Cap 88 is rotatedin the direction shown by arrow D or arrow DD such that threaded innersurface 80 engages the threaded outer surface of collet 84 and cap 88translates relative to collet 84 in the direction shown by arrow E. Cap88 is translated in the direction shown by arrow E until angled innersurface 92 engages the outer surface of collet 84 causing inner surface74 to engage cannula 78 such that cannula 78 is fixed relative to member72. Member 72 is then rotatable to a selected trajectory relative toaxis A such that cannula 78 is positioned adjacent the bone disorder.Member 72 is then moved from the first orientation to the secondorientation such that cannula 78 is fixed in the selected trajectory.

An inflatable bone tamp may then be delivered through cannula 78 to alocation adjacent the bone disorder or defect. The inflatable bone tampmay then be expanded to create a cavity or void in the bone bydelivering a material, such as, for example, saline, a contrast solutionor compressed air into an expandable member of the inflatable bone tamp,such as, for example, a balloon, to move the balloon from an unexpandedconfiguration to an expanded configuration. As the balloon moves fromthe unexpanded configuration to the expanded configuration, the ballooncreates a void in the bone having the defect or disorder. Member 72maintains cannula 78 in a stabilized orientation with respect to thebody such that a single practitioner can insert the inflatable bone tampthrough cannula 78 and operate the inflatable bone tamp in a steadymanner. That is, cannula 78 remains at the selected trajectory such thata distal end of cannula 78 is positioned adjacent the bone defect,without the need for a physician or physician's assistant to holdcannula 78.

After the void is formed in the bone, the inflatable bone tamp isremoved from cannula 78. Bone filler material is then delivered throughcannula 78 or a separate delivery tool configured to deliver bone fillermaterial disposed in passageway 76 and into the void so as to at leastpartially fill the void and realign fragments of the fracture and/orelevate collapsed bone to its proper height. Member 72 maintains cannula78 in a stabilized orientation with respect to the body such that asingle practitioner can administer the bone filler material in a steadymanner. That is, cannula 78 remains at the selected trajectory such thata distal end of cannula 78 is positioned adjacent the bone defect,without the need for a physician or physician's assistant to holdcannula 78. It is envisioned that the bone filler material may includeautograft, allograft, demineralized bone matrix, mineral composites,blocks, granules and pellets and bone cement, such as, for example,polymethylmethacrylate (PMMA)-based material (Kyphon HV-R, ActivOs,ActivOs 10, Xpede), calcium phosphate (Skaffold, Norian, Hydroset,KyphOs FS) and calcium sulfate (OsteoSet), as well as other injectables.

In one embodiment, system 30 includes an agent, which may be disposed,packed or layered within, on or about the components and/or surfaces ofthe components of system 30, such as, for example, members 32, 72 orcannula 78. It is envisioned that the agent may include bone growthpromoting material, such as, for example, bone graft to enhance fixationof the fixation elements with the bone in need of repair. It is furthercontemplated that the agent may include therapeutic polynucleotides orpolypeptides. It is further contemplated that the agent may includebiocompatible materials, such as, for example, biocompatible metalsand/or rigid polymers, such as, titanium elements, metal powders oftitanium or titanium compositions, sterile bone materials, such asallograft or xenograft materials, synthetic bone materials such as coraland calcium compositions, such as HA, calcium phosphate and calciumsulfite, biologically active agents, for example, gradual releasecompositions such as by blending in a bioresorbable polymer thatreleases the biologically active agent or agents in an appropriate timedependent fashion as the polymer degrades within the patient. Suitablebiologically active agents include, for example, BMP, Growth andDifferentiation Factors proteins (GDF) and cytokines. The components ofsystem 30 can be made of radiolucent materials such as polymers.Radiomarkers may be included for identification under x-ray,fluoroscopy, CT or other imaging techniques. It is envisioned that theagent may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.The embodiments above can also be modified so that some features of oneembodiment are used with the features of another embodiment. One skilledin the art may find variations of these embodiments, which,nevertheless, fall within the spirit of the present disclosure, whosescope is defined by the claims set forth below.

What is claimed is:
 1. A device for holding a surgical tool duringsurgery on a patient, the device comprising: a first member defining alongitudinal axis, the first member having a distal end, the distal endbeing configured for attachment to the patient, and a proximal endspaced away from the distal end, the proximal end including a firstportion extending from the proximal end toward the distal end, and asecond portion extending from the proximal end toward the distal end,the first portion being spaced apart from the second portion in adirection substantially transverse to the longitudinal axis by a gap,the gap extending parallel to the longitudinal axis, an inner surface ofthe first portion and an inner surface of the second portion defining acavity; a pivoting member movably disposed in the cavity including aninner surface defining a passageway; and a second member disposed withinthe passageway, the second member including an inner surface defining asecond passageway, the second passageway having a bone void fillerdisposed therein; wherein the pivoting member is movable between a firstorientation such that the gap has a first width in the directionsubstantially transverse to the longitudinal axis and the pivotingmember is rotatable to a selected trajectory relative to thelongitudinal axis, and a second orientation such that the gap has asecond width in the direction substantially transverse to thelongitudinal axis that is less than the first width and the secondmember is fixed in the selected trajectory.
 2. A device according toclaim 1, wherein the cavity is substantially spherical.
 3. A deviceaccording to claim 1, wherein the pivoting member is substantiallyspherical.
 4. A device according to claim 1, wherein a deformablematerial is disposed about at least a portion of the cavity, thedeformable material being configured to maintain the pivoting member inthe second orientation.
 5. A device according to claim 1, wherein thefirst portion and the second portion are each resiliently biased awayfrom one another.
 6. A device according to claim 1, wherein the firstportion includes a post extending parallel to the longitudinal axishaving an eyelet defining an opening extending perpendicular to thelongitudinal axis and the second portion includes a hook configured fordisposal in the opening to fix the first portion with the secondportion, wherein the hook is spaced apart from the opening when thepivoting member is in the first orientation and the hook is disposed inthe opening when the pivoting member is in the second orientation.
 7. Adevice according to claim 1, wherein the pivoting member includes afirst end comprising a ball and a second end comprising a collet, andthe device further comprises a cap having an inner surface configured toengage an outer surface of the collet.
 8. A device according to claim 7,wherein the outer surface of the collet and the inner surface of the capare threaded, the threads on the outer surface of the collet beingconfigured to engage the threads on the inner surface of the cap.
 9. Adevice according to claim 8, wherein the inner surface of the capincludes a threaded first portion and a second portion extending fromthe first portion that is free of threads, the second portion definingan angled surface.
 10. A device according to claim 8, wherein the cap ismovable between a first orientation such that the angled inner surfaceof the cap is spaced apart from the outer surface of the collet and thesecond member is movably disposed within the passageway and a secondorientation such that the angled inner surface of the cap engages theouter surface of the collet and the second member is fixed within thepassageway.
 11. A device according to claim 7, wherein the outer surfaceof the collet and the inner surface of the cap are threaded, and whereinthe cap is movable between a first orientation such that the threadedinner surface of the cap is spaced apart from the threaded outer surfaceof the collet and the second member is movably disposed within thepassageway and a second orientation such that the threaded inner surfaceof the cap engages the threaded outer surface of the collet and thesecond member is fixed within the passageway.
 12. A device according toclaim 1, wherein the first member includes at least one apertureextending transverse to the longitudinal axis and at least one openingextending perpendicular to the longitudinal axis, the openings beingconfigured to receive pins for attachment of the device to a patient.13. A device for holding a surgical tool comprising: a first memberextending along a longitudinal axis between a first end and a secondend, the first end including a first portion spaced apart from a secondportion by a gap extending parallel to the longitudinal axis, an innersurface of the first portion and an inner surface of the second portiondefining a cavity; a pivoting member movably disposed in the cavityincluding an inner surface defining a passageway; and a second memberdisposed within the passageway; wherein the pivoting member is movablebetween a first orientation such that the gap has a first width and thepivoting member is rotatable to a selected trajectory relative to thelongitudinal axis and a second orientation such that the gap has asecond width that is less than the first width and the second member isfixed in the selected trajectory; and wherein the first portion includesa post extending parallel to the longitudinal axis and the secondportion includes a hook configured to engage the post to fix the firstportion relative to the second portion, wherein the hook is spaced apartfrom the post when the pivoting member is in the first orientation andthe hook engages the post when the pivoting member is in the secondorientation.
 14. A device for holding a surgical tool comprising: afirst member extending along a longitudinal axis between a first end anda second end, the first end including a first portion spaced apart froma second portion by a gap extending parallel to the longitudinal axis,an inner surface of the first portion and an inner surface of the secondportion defining a substantially spherical cavity, the first portionincluding a post extending parallel the longitudinal axis and the secondportion including a hook configured to engage the post to fix the firstportion relative to the second portion; a substantially sphericalpivoting member movably disposed in the cavity including an innersurface defining a passageway, the cavity and the pivoting memberdefining a ball and socket joint; and a second member disposed withinthe passageway, the second member including an inner surface defining asecond passageway having an inflatable bone tamp or a bone void fillerdisposed therein, wherein the pivoting member is movable between a firstorientation such that the gap has a first width and the pivoting memberis rotatable to a selected trajectory relative to the longitudinal axisand a second orientation such that the gap has a second width that isless than the first width and the second member is fixed in the selectedtrajectory, and wherein the hook is spaced apart from the post when thepivoting member is in the first orientation and the hook engages thepost when the pivoting member is in the second orientation.